A vaginal bowel-control system for the treatment of fecal incontinence

Holly E. Richter, Catherine A. Matthews, Tristi W. Muir, Michelle M. Takase-Sanchez, Douglass S. Hale, Douglas Van Drie, Madhulika G. Varma

Research output: Contribution to journalArticlepeer-review

29 Scopus citations

Abstract

OBJECTIVE: To evaluate the effectiveness and safety of a vaginal bowel-control device and pump system for fecal incontinence treatment. METHODS: Women with a minimum of four fecal incontinence episodes over 2 weeks were fit with the intravaginal device. Treatment success, defined as a 50% or greater reduction of incontinent episodes, was assessed at 1 month. Participants were invited into an optional extended-wear period of another 2 months. Secondary outcomes included symptom improvement measured by the Fecal Incontinence Quality of Life, Modified Manchester Health Questionnaire, and Patient Global Impression of Improvement. Adverse events were collected. Intention-to-treat analysis included participants who were successfully fit entering treatment. Per protocol, analysis included participants with a valid 1-month treatment diary. RESULTS: Sixty-one of 110 (55.5%) participants from six clinical sites were successfully fit and entered treatment. At 1 month, intention-to-treat success was 78.7% (48/61, P

Original languageEnglish (US)
Pages (from-to)540-547
Number of pages8
JournalObstetrics and Gynecology
Volume125
Issue number3
DOIs
StatePublished - Mar 27 2015

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Medicine(all)

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